Enzalutamide With Venetoclax in Treating Patients With Metastatic Castration Resistant Prostate Cancer

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT03751436
Phase
PHASE1
Status
Completed

Conditions

  • Castration Levels of Testosterone
  • Castration-Resistant Prostate Carcinoma
  • Metastatic Prostate Carcinoma
  • Metastatic Prostate Carcinoma in the Soft Tissue
  • PSA Progression
  • Prostate Carcinoma Metastatic in the Bone
  • Stage IV Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enzalutamide — DRUG
    Given PO
  • Venetoclax — DRUG
    Given PO

Study Details

This phase Ib/II trial studies the side effects and best dose of venetoclax when given together with enzalutamide and to see how well they work in treating patients with castration resistant prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, may lessen the amount of androgens made by the body. Venetoclax may target a special group of prostate cancer cells that is known to lead to resistance to treatment. Giving enzalutamide and venetoclax may work better in treating patients with castration resistant prostate cancer.

Key Dates

Start date
Aug 2, 2019
Status verified
Oct 2023
Primary completion
Jul 18, 2022
Completion
Aug 11, 2023

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (venetoclax, enzalutamide)
    Patients receive venetoclax PO QD and enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose (MTD) (Phase Ib) [ Time Frame: Up to 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263-

Find similar trials in Buffalo, NY

By research site
Roswell Park Cancer Institute· Buffalo, NY

Related Studies